Koneksa Insights
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Case Study
Redefining Pain Episodes in Sickle Cell Disease
Discover how patients living with sickle cell disease redefined the “pain crisis” and revealed a pain episode structure that utilization-based endpoints never see.
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Lodestar™: Your North Star for Regulatory Submissions
Discover the intelligent submission software behind every Koneksa biometrics program, validated to cut programming time 80%, speed QC cycles 16x, and lower biometrics costs 65%.
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Lodestar™ vs. the Traditional Submission Stack: A Side-by-Side Comparison
See exactly where the traditional submission stack loses weeks, and how a connected workflow turns six-week SDTM mapping cycles into days.
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Biometrics Services
Get biometrics without the trade-off power by Lodestar™ Intelligent Submission Software: 65% lower costs, 16x faster QC cycles, and submission-grade quality, delivered by our team, licensed to yours, or both.
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Driving Novel Endpoints and Study Designs In Amyotrophic Lateral Sclerosis
This pre-print examines ALSFRS-R subdomains in Amyotrophic Lateral Sclerosis (ALS) clinical studies, finding that fine and gross motor subdomains may be more sensitive to disease progression and presenting a novel non-linear method for defining fast and slow progressors.
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Study Design Considerations for Digital Assessments in Parkinson’s Disease Clinical Trials
Compare how in-clinic, burst, and weekly at-home assessment schedules change the sample size a Parkinson’s disease-modifying therapy trial needs to detect an effect.
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Compliance Analysis for Remote Spirometry in Mild to Moderate Asthma
See what 3,024 expected pulmonary function tests across three asthma studies reveal about whether patients reliably complete twice-daily spirometry at home.
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Cardiac Biomarkers in Fabry Disease
See how patients and clinicians shaped a composite cardiac biomarker concept for Fabry disease, combining wearables, ECG, diaries, and PROs into one measurement model.
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Considerations for Conducting Bring Your Own “Device” (BYOD) Clinical Studies
Find out what sponsors need to plan for when designing Bring Your Own Device (BYOD) clinical studies, capturing more representative, free-living participant data without the biases of single-timepoint clinic visits.
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Found 58 Results
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Article
What Digital Measures Are Really Capturing in Parkinson’s Disease and Why It Matters for Clinical Trials
Insights from new peer-reviewed research by Koneksa during Parkinson's Awareness Month Behind Every Dataset is a Lived Experience. In Parkinson’s disease, symptoms do not progress in neat, linear steps.... Download
Article
5 Questions to Ask Before Choosing a Digital Biomarkers Partner
Introduction The adoption of digital biomarkers in clinical trials is accelerating rapidly, driven by wearable sensors, decentralized trial models, and the demand for continuous patient monitoring. As sponsors increasingly explore... Download
Article
Designing Evidence That Reflects Everyone: A Black History Month Perspective
Diversity in clinical trials is not only a social imperative, it is a scientific standard. February, during Black History Month, offers an important moment to reflect on both the historical... Download
